Long-term changes in international health policy are needed to address future outbreaks in countries with inadequate public health infrastructure.

Bioethicists have important role to play

Much of the ethical debate involving Ebola has centered on whether healthcare workers should be quarantined, and how clinical trials should be run.

"There is less discussion about the ethical issues that really have to do with the global health situation," says Mary Devereaux, PhD, director of biomedical ethics seminars and assistant director of the research ethics program at The University of California, San Diego. "Both for ethical and pragmatic reasons, the issue of inequity in global health is one that we need to address."

The Ebola epidemic spotlights the fact that there are parts of the world with completely inadequate public health infrastructure. "This is not going to be the last outbreak of some unexpected infectious disease. But until the effects of such outbreaks come to the U.S., people tend to be highly indifferent," says Devereaux. The lack of healthcare infrastructure in developing countries is the most fundamental ethical issue Devereaux sees with Ebola, but it remains to be seen whether long-term changes in international health policy will occur.

"If the Ebola epidemic occurred somewhere other than Africa, my guess is that we would have responded with more urgency," says Devereaux. "I think there is a racial and cultural dimension to this crisis that can get missed."

Bioethicists can shift the discussion to our ethical obligations to low-resource countries as members of a shared community.

"Even if you don’t buy the ethical argument that we’re all connected, the fight to contain Ebola does demonstrate that, in terms of infectious disease, we are all connected," says Devereaux.

Here are experts’ other primary ethical concerns involving Ebola:

Engaging the local population.

Ethical concerns involving prevention and treatment of Ebola mirror those surrounding other public health threats in developing countries. Involving the local population is one example.

"The central role of bioethicists is to make sure the conversation is grounded in the countries where the problem is, rather than conference centers in first world countries," says Steven Miles, MD, professor and Maas Family Endowed Chair in Bioethics at the University of Minnesota Medical School’s Center for Bioethics in Minneapolis.

Miles saw great success using this approach to control neonatal tetanus at a refugee camp in Cambodia. "I found a sentence in an infectious disease textbook that said that Japan got rid of neonatal tetanus after WWII by changing cord care practices," he says. A midwife who spoke fluent Cambodian met with local midwives to discuss cord care.

During the lengthy discussion that ensued, it was discovered that many were comforting crying babies by grinding up wasp nests with contaminated ground water, and placing the mixture onto the infant’s umbilical cord. "Since the cord was just cut, it was a fresh open wound, and they were inoculating the kid with clostridia," says Miles.

After the local midwives learned this practice was harmful, however, they stopped it. "Instantly, we saw a 90% drop in neonatal tetanus. The only cases we were seeing came from outside the camp," says Miles.

Finding a way to refrigerate tetanus vaccine was a costly, logistically difficult problem to solve. In contrast, a simple conversation "really changed the game on neonatal tetanus," says Miles.

The same is true regarding Ebola transmission, he notes, after local populations were educated on funeral and burial practices. "It’s clear that that locally based measures regarding changing how bodies are prepared for funeral and how they’re buried is the most cost-effective strategy to meeting the immediate needs of the epidemic," says Miles.

Researchers and health officials, Miles says, "should be very careful about not allowing our natural tendency to think about prevention, particularly in relation to innovative drugs, to divert resources away from highly effective strategies that can be applied now at the village and township levels."

Challenges in obtaining informed consent.

Informed consent is a central ethical issue involving clinical trials for an Ebola vaccine, according to Donald P. Owens, Jr., PhD, James A. Knight, MD Chair of Humanities and Ethics in Medicine Chaplain at Tulane University School of Medicine in New Orleans.

"It is imperative that those involved with the design of the clinical trials take time to fully educate the patients involved in the trials, both pros and cons," says Owens. This will involve speaking in terms that can be readily understood by the patients and their families.

The poverty of the affected population must be considered, Devereaux says.

"International aid workers don’t want to do anything that appears to be lowering ethical standards because people are in less developed parts of the world," Devereaux explains.

Some argue it’s unethical for experimental Ebola treatments to be given in randomized, controlled trials, since this requires that some patients not get the experimental treatment.

"The argument in favor of randomized, controlled trials is the usual scientific and ethical one," Devereaux says. "We have a research design that is familiar and tested and gives us rigorous results."

The ethical challenge in using randomized trials is that there doesn’t appear to be clinical equipoise — a situation in which researchers have no reason to think one treatment better than another, or better than no intervention at all.

"I’m not sure we have clinical equipoise in the case of Ebola — certainly not in the setting of countries like Sierra Leone, where mortality is 50% or higher," Devereaux says.

Researchers may have reason to believe that a given intervention has been protective or has improved the odds for people already infected with Ebola. In this case, if patients are informed and fully aware that they’re being offered an experimental vaccine or treatment, says Devereaux, "it seems to me, then, that there may be an argument against the standard of randomized controlled trials."

Many healthcare workers, for instance, were given blood products from recovered Ebola patients. "Some argue that since the death rate is higher, you can do things that are riskier," says Devereaux. "However, we need to be careful that we don’t lower the bar for consent or rigorous trial design and data collection."

Treatments must be accessible to the local population, Miles says.

A primary ethical concern with research projects conducted in low-resource countries, says Miles, "is that that we tend to price the resulting products at a level that those countries can’t afford."

According to guidelines from the Council for International Organizations of Medical Sciences, research projects in low-resource countries should ensure that "any product developed is made reasonably available to them, and as far as possible leave the population in a better position."1

"In the case of Ebola, which is highly localized in extremely poor countries, the idea that one would develop a vaccine that would charge first world rates is not an acceptable strategy," Miles says.

Reference

Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Bull Med Ethics 2002; 182:17-23.